Dimia tablets film-coated

Kraj: Armenia

Język: angielski

Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Składnik aktywny:

drospirenone, ethinylestradiol

Dostępny od:

Gedeon Richter PLC

Kod ATC:

G03AA12

INN (International Nazwa):

drospirenone, ethinylestradiol

Dawkowanie:

3mg+ 0,02mg

Forma farmaceutyczna:

tablets film-coated

Sztuk w opakowaniu:

(28/1x28/) and (84/3x28/) in blister

Typ recepty:

Prescription

Status autoryzacji:

Registered

Data autoryzacji:

2017-12-08

Charakterystyka produktu

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1.
NAN{E
OF
THB
MEDICINAL
PRODUCT
Dimia
3
rng/0.02
mg
film-coatecl
tablets
2.
QUALITATIVE
AND
QUANTITATIVB
COMPOSITION
24
rvhite
or
almosf
white
(active)
film-coated
tablets:
Each
filni-coated
tablet
coutains
3
mg drospirerlone
and
0.02 rng
ethinylestradiol,
Excipients
with
knorvn effect:
Each
film-coatect
tablet
contains 48.53
mg
of
lactose
monohydrate
and 0.070
mg
of
soya leoithin.
4
green
placebo
(inactive)
film-coated
tablets:
The
tablet
does
not
contain
active
sutrstances.
Excipients
rvith
lq[g]ytr
efftct:
lactose anhydrous
37
,26
ng,
sunset
yellow
(E
I
I0)
0,003
mg.
For
the
full
list
of
exoipients,
see
section
6.
I
3.
PIIARMACBUTICALFORIVI
Fihn-coated tablet.
The
active
tablet
is
rvhite
or
alnrost
rvhite,
round,
bicorrrrex
film-coated
tablet,
diarneter atrogt
5
mm,
Engraving
olr
one
side:
"G730',
The
placebo
tablet
is
green)
round,
biconvex
film-coated
tablet,
cliameter
about
5
mm,
4.
CLINICALPARTICUTARS
4.1
Therapeuticindications
Oral
contraception.
The
decisiolr
to
presclibe
Dimia
sl,ould
take
into
considelation the
individualrvornan's
current
risk
factors,
particularly
those
for
venous
thromboembolism
(VTE),
ancl
l:ou, the
risl<
of
VTE with
Diniia
cofiipares
with
other
combined
hormonal
coutraceptives
(CHCs)
(see
section
s
4.3
and
4.4).
4.2
Posology
and
methqd
ot'adnrinistrution
Mglhod
of.administration:
orat
use
Posology
IIow
to
take
Dimia
A
9t,ilil\l[$
$
f{/"2
//
Ixrtgr/ilAie-
AFPt
'$6$ldftAlA*
p6,
/,
The
tablets
must
be
taken every
day
at about
the
same
time,
if
necessary
rvith
a
little
liquid,
in
the
order
shown
on
the blister
pack,
Toblet
taking
is
continuous. One
tnblet
is
to
be
taken
daily
for
28
consecutive
days.
Each
subsequent
pack
is
startecl
lhe
day
after
the
Jast
tabJet
of
the
previous
paclc,
Withdrawal
bleeding
usually
starts
otr
day
?-3
after
starting
the
grern
placebo
tablets
(last
rorv)
ancl
may
not
have
finished
befcre
the
next
pach
is
starled.
Holv
to start
Dimia
c
No
preceding
horntona[
contr&ceptive
u,se
(in
the
past
montlt)
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